FDA Registration
Active
🇺🇸 United States
IntenOxy 5
Reg #: 3004972304
·
FEI: 3004972304
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CAIRE INC.
- Registration Number
- 3004972304
- FEI Number
- 3004972304
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2200 Airport Industrial Dr Ste 500
- City
- Ball Ground
- State
- GA
- ZIP
- 30107
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213825
Owner / Operator
- Firm Name
- CAIRE Inc.
- Operator Number
- 9008476
- Address
- 2200 Airport Industrial Dr, Ste 500
- City
- Ball Ground
- State
- GA
- Postal Code
- 30107
- Country
- US
- Correspondent
- Pamela S Netzel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2024-07-31 |
Proprietary Names
IntenOxy 5
Establishment Types
Repack or Relabel Medical Device